Study Stopped
251PP301(PASSPORT) primary endpoint was not met;Biogen decision to close the study early. There were no safety concerns with the PASSPORT study.
Study of BIIB092 in Participants With Progressive Supranuclear Palsy
PASSPORT
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants With Progressive Supranuclear Palsy
3 other identifiers
interventional
490
12 countries
84
Brief Summary
The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 \& 4 laboratory abnormalities. The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2017
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2017
CompletedFirst Posted
Study publicly available on registry
March 1, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2020
CompletedResults Posted
Study results publicly available
December 21, 2020
CompletedDecember 21, 2020
November 1, 2020
2.3 years
February 27, 2017
September 3, 2020
November 25, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52
The PSPRS is a quantitative measure of disability in participants with PSP. The PSPRS comprises 28 items in 6 areas. Six items are rated on a 3-point scale (0-2) and 22 are rated on a 5-point scale (0-4). The 6 areas are the History/Daily Activities, Mentation, Bulbar, Ocular Motor, Limb Motor, and Gait. The 28-item PSPRS total score ranges from 0 (normal) to 100. Fifteen items are selected to form a 15-item PSPRS and three domains are identified: Gait/Limb function, Ocular Motor, and Bulbar. The total 15-item PSPRS score ranges from 0 (normal) to 52. A positive change from baseline indicates worsening.
Baseline, Week 52
Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug
AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity.
up to 52 weeks
Secondary Outcomes (13)
Change From Baseline in Movement Disorder Society (MDS)-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52
Baseline, Week 52
Clinical Global Impression of Change (CGI-C) Scale Score
Week 52
Change From Baseline in Progressive Supranuclear Palsy (PSP)-Cognitive Composite Battery Z-Score at Week 52
Baseline, Week 52
Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) Scale at Week 52
Baseline, Week 52
Change From Baseline in Progressive Supranuclear Palsy Quality of Life Scale (PSP-QoL) Score
Baseline, Week 52
- +8 more secondary outcomes
Study Arms (2)
BIIB092
EXPERIMENTALParticipants will receive BIIB092 50 mg/ml intravenous (IV) infusion once every 4 weeks for 48 weeks in double blind treatment period followed by BIIB092 50 mg/ml IV infusion once every 4 weeks starting at Week 52 up to Week 208.
Placebo
PLACEBO COMPARATORParticipants will receive BIIB092 matching placebo IV infusion once every 4 weeks for 48 weeks in double blind treatment period followed by BIIB092 50 mg/ml IV infusion once every 4 weeks starting at Week 52 up to Week 208.
Interventions
Eligibility Criteria
You may qualify if:
- Participants with probable or possible PSP
- Able to ambulate independently or with assistance
- Able to tolerate MRI
- Have reliable caregiver to accompany participant to all study visits
- Score greater or equal to 20 on the Mini Mental State Exam (MMSE) at screening
- Participant must reside outside a skilled nursing facility or dementia care facility at the time of screening and admission to such a facility must not be planned
You may not qualify if:
- Presence of other significant neurological or psychiatric disorders
- Diagnosis of amyotrophic lateral sclerosis (ALS) or other motor neuron disease
- History of early, prominent rapid eye movement (REM) sleep behavior disorder
- History of or screening brain MRI scan indicative of significant abnormality
- Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean for the laboratory performing the assay
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (86)
Research Site
Phoenix, Arizona, 85013, United States
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Scottsdale, Arizona, 85259, United States
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Sun City, Arizona, 85351, United States
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Fountain Valley, California, 92708, United States
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La Jolla, California, 92037, United States
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Los Angeles, California, 90095, United States
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San Francisco, California, 94158, United States
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Boca Raton, Florida, 33486, United States
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Gainesville, Florida, 32607, United States
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Tampa, Florida, 33612-4742, United States
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Chicago, Illinois, 60611, United States
Research Name
Chicago, Illinois, 60612-3841, United States
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Chicago, Illinois, 60637-1447, United States
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Indianapolis, Indiana, 46202-2280, United States
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Kansas City, Kansas, 66160, United States
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New Orleans, Louisiana, 70121-2429, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21287, United States
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Boston, Massachusetts, 02114, United States
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Burlington, Massachusetts, 01702, United States
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Farmington Hills, Michigan, 48334, United States
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Minneapolis, Minnesota, 55455-0341, United States
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New Brunswick, New Jersey, 08901, United States
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Albany, New York, 12208, United States
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New York, New York, 100029, United States
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New York, New York, 10029, United States
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New York, New York, 10032-3725, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19104, United States
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Charleston, South Carolina, 29425, United States
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Dallas, Texas, 75390-8869, United States
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Charlottesville, Virginia, 22908-0394, United States
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Seattle, Washington, 98122, United States
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North Melbourne, Victoria, Australia
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Innsbruck, Tyrol, Austria
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Vienna, Austria
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Bordeaux, France
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Lille, France
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Marseille, France
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Nîmes, France
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Paris, France
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Rennes, France
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Toulouse, France
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Munich, Bavaria, Germany
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Marburg, Hesse, Germany
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Rostock, Mecklenburg-Western-Pommerania, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Dresden, Saxony, Germany
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Kiel, Schleswig-Holstein, Germany
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Lübeck, Schleswig-Holstein, Germany
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Beelitz-Heilstätten, Germany
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Bochum, Germany
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Bonn, Germany
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Essen, Germany
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Kassel, Germany
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Ulm, Germany
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Athens, Marousi, Greece
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Salerno, Campania, Italy
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Pisa, Italy
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Venice-Lido, Italy
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Nagoya, Aichi-ken, Japan
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Kamagaya, Chiba, Japan
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Sapporo, Hokkaido, Japan
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Sagamihara, Kanagawa, Japan
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Kodaira, Tokyo, Japan
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Yonago, Tottori, Japan
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Shizuoka, Japan
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Krasnoyarsk, Russia
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Moscow, Russia
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Seoul, South Korea
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Pamplona, Navarre, Spain
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Barakaldo, Vizcaya, Spain
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Barcelona, Spain
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Madrid, Spain
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Seville, Spain
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Valencia, Spain
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Cambridge, Cambridgeshire, United Kingdom
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Brighton, East Sussex, United Kingdom
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Southampton, Hampshire, United Kingdom
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Liverpool, Merseyside, United Kingdom
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Newcastle upon Tyne, Tyne and Wear, United Kingdom
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Newport, Wales, United Kingdom
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London, United Kingdom
Related Publications (2)
Jaeger J, Yang L, Li Y, Castrillo-Viguera C, Haeberlein SB, Dam T, O'Gorman J. Development of a cognitive composite for measuring change in progressive supranuclear palsy. Parkinsonism Relat Disord. 2021 Nov;92:94-100. doi: 10.1016/j.parkreldis.2021.10.007. Epub 2021 Oct 12.
PMID: 34736158DERIVEDDam T, Boxer AL, Golbe LI, Hoglinger GU, Morris HR, Litvan I, Lang AE, Corvol JC, Aiba I, Grundman M, Yang L, Tidemann-Miller B, Kupferman J, Harper K, Kamisoglu K, Wald MJ, Graham DL, Gedney L, O'Gorman J, Haeberlein SB; PASSPORT Study Group. Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial. Nat Med. 2021 Aug;27(8):1451-1457. doi: 10.1038/s41591-021-01455-x. Epub 2021 Aug 12.
PMID: 34385707DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study got terminated as the primary endpoint was not met. PC period was completed at the time of termination. The study was not terminated due to a safety concern.
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2017
First Posted
March 1, 2017
Study Start
June 1, 2017
Primary Completion
September 6, 2019
Study Completion
February 7, 2020
Last Updated
December 21, 2020
Results First Posted
December 21, 2020
Record last verified: 2020-11